The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 24 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
Terminal rate constant in plasma
Time frame: up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
MRTtot (total mean residence time)
Time frame: up to 24 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 24 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 24 hours after drug administration
Number of subjects with adverse events
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Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital functions
blood pressure, pulse rate, ECG
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration